Director, CDx & Clinical Platform Development
Core
Architecting long-term vision and operational framework for Companion Diagnostic (CDx) Development, Clinical Platform Development, and Biomarker Policy Innovation to advance the therapeutic pipeline from early-stage to global regulatory approvals.
Role type
Director, Scientific Operations (Translational Medicine)
Builds
Diagnostic co-development strategies, clinical platforms, and biomarker-based regulatory policy frameworks.
Domain
Biopharma / Precision Medicine / Companion Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDx and IVD development strategy, assay design and validation, regulatory pathway navigation (FDA PMA/IDE, EMA IVDR, China NMPA), team leadership (6-8 scientists), cross-functional stakeholder management, emerging diagnostic technologies (NGS, liquid biopsy, digital pathology)
Preferred skills
Regulatory science background, consortia leadership, market access and reimbursement strategy
Technologies
NGS, liquid biopsy, digital pathology, multi-omic assays, IHC, PCR
Responsibilities
Formulate diagnostic co-development strategy, oversee strategic partnerships with internal/external collaborators, manage and mentor a team of 6–8 scientific professionals, define unit priorities and budgets, cultivate alliances with regulatory and policy stakeholders
Seniority
Director, strategic leadership & team management
